BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS POWER LOAD

    MDR report key: 23267440 · Received October 10, 2025

    Report

    Report Number
    0001831750-2025-00732
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 27, 2025
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327394740
    PMA / PMN Number
    K113598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY A STRYKER FIELD SERVICE TECHNICIAN. THE ISSUE IDENTIFIED, WHICH WAS SMOKING, IS NOT REPORTABLE. HOWEVER, IT WAS FOUND THAT THE SMOKE WAS DUE TO A SHORTED TROLLEY CPU BOARD CIRCUIT. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE UNIT UNDER OE # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE'S BATTERY COMPARTMENT MAY HAVE CAUGHT ON FIRE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE'S BATTERY COMPARTMENT MAY HAVE CAUGHT ON FIRE. AFTER FURTHER INVESTIGATION, THE DEVICE DID NOT CATCH FIRE, AS THERE WAS ONLY SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124306 MTS POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327394740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown